Hepatitis B Acceptability and Vaccination Incentive Trial (HAVIT)
This prospective trial seeks to investigate the efficacy of a financial incentive in increasing the uptake and completion of the HBV vaccine series among people who inject drugs (PWID). Using a randomised controlled trial design, the investigators will offer the 3 dose, accelerated HBV schedule to eligible PWID allocated to either a standard of care or incentive condition. Participants allocated to the incentive condition will receive a small incentive payment after the second and third dose of the vaccine. It is hypothesized that the proportion of participants who complete the vaccine series in the incentive payment arm will be higher compared to the non-incentive payment arm (standard of care).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
|Official Title:||A Randomised Controlled Trial to Evaluate the Effectiveness of a Small Financial Incentive After the Second and Third Dose of a Hepatitis B Vaccine, on Vaccine Completion in People Who Inject Drugs|
- Determine, relative to a 'standard of care' control condition, the efficacy of incentive payments to increase HBV vaccine completion using an accelerated schedule (0, 7, and 21 days). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Assess the relative cost effectiveness of standard care compared to incentive payments as methods of improving rates of successful vaccine series completion and vaccine-induced immunity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Identify the correlates of immunity (defined as hepatitis B surface antibody levels greater than 10 mIU/ml) [ Time Frame: At baseline and week 12 ] [ Designated as safety issue: No ]
- Assess the acceptability of vaccines, including HBV vaccines, barriers to immunisation uptake and willingness to participate in vaccine trials among PWID [ Time Frame: At baseline and week 12 ] [ Designated as safety issue: No ]
- Assess hepatitis B-related knowledge in this group [ Time Frame: At baseline and week 12 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
No Intervention: Arm 1
Participants in Arm 1 will not receive any financial incentive after the second and third dose of hepatitis B vaccine have been administered.
Participants in Arm 2 will receive a small financial incentive after the second and third dose of the hepatitis B vaccine
Other: Incentive condition
Receipt of a small financial incentive after the second and third dose of the hepatitis B vaccine
Injecting drug use is the leading exposure category for notifications of newly acquired hepatitis B virus (HBV) infection in Australia. Despite the existence of a safe and efficacious vaccine, hepatitis B coverage remains low among Australian people who inject drugs (PWID) and little is known about attitudes to immunisation, barriers to uptake and willingness to participate in vaccine trials among this group. Candidate vaccines for hepatitis C virus (HCV) and HIV are currently in development and HBV immunisation provides a surrogate for examining strategies to deliver vaccines to this group.
Secondary objectives of this trial are to (i) assess the cost effectiveness of the interventions; (ii) identify the correlates of immunity in this group; (iii) assess the acceptability of vaccines, including HBV vaccines, barriers to immunisation uptake and willingness to participate in vaccine trials among PWID; and (iv) assess hepatitis B−related knowledge in this group.
Research Design: A total of 200 eligible PWID or people at risk of initiating injecting (those with no history of exposure to or receipt of more than one vaccination against HBV) will be recruited and interviewed prior to randomisation on a 1:1 basis (100 per arm) to either the (1) control (standard of care) or (2) incentive conditions. All participants will be offered the 3 dose accelerated vaccine schedule (20ug at 0, 7 and 21 days) and will be followed up at week 12.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744289
|Australia, New South Wales|
|The Kirby Institute|
|Sydney, New South Wales, Australia|
|Principal Investigator:||Lisa Maher, PhD||Kirby Institute|